In this one-day stage 3 data integrity/governance course, we discuss effective techniques to influence meaningful and effective change within an organization’s data integrity/data governance strategy. This is an advanced workshop using train-the-trainer methodology; participants will gain the insight necessary to develop and communicate patient-centric solutions for the future based on a foundation of regulatory compliance. Insights gained from Stage 1 and 2 workshops will be combined to develop a “subject matter expert” approach to data science within a GXP environment. Influencers will gain the background necessary to:
develop risk-based strategies for large-scale shifts in corporate/business data integrity resources,
practice presenting the long-term benefits of modern risk management tools to senior management, through mock classroom presentation scenarios,
determine how to integrate new risk management tools, such as data/process mapping, into an existing Quality System without disruption of ongoing activities,
develop simple employee training programs tailored to the evolving regulatory landscape and use of new data integrity and data governance tools, and
quickly and effectively field questions or concerns during interaction with regulators/customers.
Who should join the Stage 3 Influencer course? Individuals working within a GXP environment that:
Plan, develop, and/or execute employee training in the area of data integrity/data governance,
Plan, develop, and/or execute modern risk management tools within an existing Quality System
Field data integrity related questions (written or verbal) during regulatory or customer interaction
Plan, develop and/or influence change with a site/business data governance strategy